Clinical Trials Research Assistant/Data Manager- Radiology

UIOWA • Iowa City, IA

14h • Onsite

About The Position

The University of Iowa Health Care, Department of Radiology is seeking a Clinical Trials Research Assistant/Data Manager! The Clinical Trials Research Assistant/Data Manager is responsible for performing clinical/health care research activities in support of clinical trials in the Department of Radiology. Assist in the design, development, execution, administration and maintenance of protocols and clinical studies. Screen recruit, enroll and obtain informed consent of clinical research activities. Participate in the design, development, and testing of clinical research trial data systems. Mange and organized regulatory documentation. Position Responsibilities: Key Areas of Responsibility Research/Clinical Activities; Subject Recruitment and Enrollment Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects. Assist with subject recruitment by mining databases and EPIC. Assist with clinical and data coordination for research activities and set up supplies for study visits. Participates in clinical research visits, which includes Epic documentation, checking vitals, provision of research questionnaires, patient education, and coordination of future research visits Coordinate day-today clinical trial operations within the procedural environment Serve as primary liaison among participants, investigators, clinical staff, sponsors, CROs, and imaging core labs Schedule and coordinate study visits, procedures, imaging, laboratory testing, and follow-up appointments Prepare and manage investigational decides, procedural kits, and study supplies Coordinate post-procedure monitoring, discharge instructions, and follow-up care Collect and document clinical assessments, labs, imaging, radiation exposure, and contrast use Track and report adverse events, serious adverse events, and unanticipated problems Provide patient education related to procedures, medications, and follow-up requirements Data Collection and Monitoring Assist in managing data, including the storage, reporting and auditing to assess quality assurance Perform all data processing tasks; enter data, verify data, generate queries, etc. Coordinate the processing of data from various sites/centers/studies Ensure accurate documentation of procedural, device, and imaging data Respond to data queries and maintain data quality Prepare for and participate in monitoring visits and audits Maintain drug/device accountability and reconciliation logs Regulatory Guidelines and Documents Assist with the submission of IRB protocols, work with department Regulatory Specialist to ensure timely updating of information for submissions Ensure compliance with GCP, FDA regulations, and institutional policies Maintain training and delegation documentation Support regulatory audits and inspections Protocol Development/Management and Study Responsibilities Consult with researchers to assist in study planning, development and support of a data management plan, design forms to facilitate the collection and tracking of study participant data, drugs, specimens and study procedures Design and coordinate field tests for data collecting forms and assist in the design of these procedures Manages and maintain protocols Research, change, and submit protocol amendments for IRB approval Prepares IRB documents for protocol approval, modifications and yearly renewals Monitors protocol status as it is process through the IRB Assist in conducting training of new protocols and changes to existing protocols Assist with feasibility assessments and study start-up activities Review protocols for operational feasibility and workflow integration Coordinate site initiation, investigator meetings, and sponsor communications Support in tracking study milestones, enrollment targets, and budgets Support study close-out activities and document archiving Human Resources/Leadership May provide training to other research staff as required by the study protocol The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job. University of Iowa Health Care—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. ®

Requirements

• Bachelor’s Degree in a STEM (Science, Technology, Engineering, or Math) or related educational field or an equivalent combination of education and experience is required.
• Six months-one year of clinical research experience is required.
• Excellent written, verbal communication, interpersonal and organizational skills are required.
• Ability to fluctuate occasionally working nights and weekends to enroll patients and/or monitor study patients as may be required by the enrollment protocol of the study.
• Experience working with patients in a hospital or clinical setting including providing care and reviewing medical information.
• Knowledge of Microsoft Office Word, Excel, PowerPoint, Outlook, Adobe Acrobat

Nice To Haves

• Ability to work independently and manage multiple priorities or studies at one time.
• Previous experience and participation with clinical trials is highly desired.
• Knowledge of regulatory guidelines and procedures as set forth by the IRB is highly desired.
• Research protocol management experience including single and multi-institutional studies
• Experience with medical research data management
• Experience with laboratory functions including, blood draws, IV placement, processing specimens per protocol, as well as storage of specimens, maintaining lab areas, inventories, orders.
• Experience working with Epic, RedCap, Clinicaltrials.gov and IRB submission systems.

Responsibilities

• Research/Clinical Activities
• Subject Recruitment and Enrollment Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects.
• Assist with subject recruitment by mining databases and EPIC.
• Assist with clinical and data coordination for research activities and set up supplies for study visits.
• Participates in clinical research visits, which includes Epic documentation, checking vitals, provision of research questionnaires, patient education, and coordination of future research visits
• Coordinate day-today clinical trial operations within the procedural environment
• Serve as primary liaison among participants, investigators, clinical staff, sponsors, CROs, and imaging core labs
• Schedule and coordinate study visits, procedures, imaging, laboratory testing, and follow-up appointments
• Prepare and manage investigational decides, procedural kits, and study supplies
• Coordinate post-procedure monitoring, discharge instructions, and follow-up care
• Collect and document clinical assessments, labs, imaging, radiation exposure, and contrast use
• Track and report adverse events, serious adverse events, and unanticipated problems
• Provide patient education related to procedures, medications, and follow-up requirements
• Data Collection and Monitoring Assist in managing data, including the storage, reporting and auditing to assess quality assurance
• Perform all data processing tasks; enter data, verify data, generate queries, etc.
• Coordinate the processing of data from various sites/centers/studies
• Ensure accurate documentation of procedural, device, and imaging data
• Respond to data queries and maintain data quality
• Prepare for and participate in monitoring visits and audits
• Maintain drug/device accountability and reconciliation logs
• Regulatory Guidelines and Documents Assist with the submission of IRB protocols, work with department Regulatory Specialist to ensure timely updating of information for submissions
• Ensure compliance with GCP, FDA regulations, and institutional policies
• Maintain training and delegation documentation
• Support regulatory audits and inspections
• Protocol Development/Management and Study Responsibilities Consult with researchers to assist in study planning, development and support of a data management plan, design forms to facilitate the collection and tracking of study participant data, drugs, specimens and study procedures
• Design and coordinate field tests for data collecting forms and assist in the design of these procedures
• Manages and maintain protocols
• Research, change, and submit protocol amendments for IRB approval
• Prepares IRB documents for protocol approval, modifications and yearly renewals
• Monitors protocol status as it is process through the IRB
• Assist in conducting training of new protocols and changes to existing protocols
• Assist with feasibility assessments and study start-up activities
• Review protocols for operational feasibility and workflow integration
• Coordinate site initiation, investigator meetings, and sponsor communications
• Support in tracking study milestones, enrollment targets, and budgets
• Support study close-out activities and document archiving
• Human Resources/Leadership May provide training to other research staff as required by the study protocol

Benefits

• Regular salaried position.
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level